JP2001522996A - Device for reading multiple biological indicators - Google Patents

Abstract

The device reads multiple biological indicators (BI) to determine the effectiveness of multiple sterilization cycles. Each BI expresses fluorescence corresponding to biological activity indicative of bacterial growth within said BI. The plurality of BI holders are each configured to receive one of the plurality of BIs. The carriage is controllably movable with respect to the plurality of BI holders to a position near each of the BI holders. A fluorescence sensor is mounted on the carriage and arranged to detect the fluorescence developed by the BI contained in the BI container in the selected BI holder. The controller is coupled to the fluorescent sensor and receives a fluorescent signal and transmits an output signal indicating the detected fluorescent light.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001] This application was filed May 30, 1997, entitled "BIOLOGICAL STERILITY INDICATOR" (Biological Sterility Indicator), and is filed under the name of Minnesota Mining and Manufacturing.
No. 08 / 886,894 and May 5, 1997, assigned to the Company.
"SYSTEM FOR MEASURING THE EFFICAC"
Claim priority of application No. 08 / 856,104, filed under the title "Y OF A STERILIZATION CYCLE" (system for measuring the effectiveness of sterilization cycles) and assigned to the Minnesota Mining and Manufacturing Company.

[0002] The present invention relates to a system for determining the effectiveness of a sterilization cycle. More specifically, the present invention relates to a system for reading fluorescence from a biological sterility indicator to determine the effectiveness of a sterilization cycle.

[0003] Sterilization of equipment and devices is important in some industries. For example, hospitals and other healthcare facilities must commonly and frequently sterilize equipment and devices used to treat patients. The particular type of sterilization cycle used to sterilize such equipment can vary based on the particular equipment or device being sterilized and depending on the particular preferences of the entity performing the sterilization cycle. . However, all such sterilization cycles or processes are generally designed to kill organisms that would otherwise contaminate the equipment or equipment being sterilized.

[0004] Sterilization is performed at different sterilization cycles using different methods or techniques. For example, such a sterilization cycle may involve steam, dry heat,
Includes management of chemicals or radiation. For steam sterilization, the sterilized equipment is set to 121 to 132.
It is generally effective when exposed to ° C steam. The device to be sterilized preferably performs steam sterilization at 132 ° C. for about 3 minutes and at 121 ° C. for 30 minutes. One form of chemical sterilization involves exposing the sterilized device to ethylene oxide gas. The sterilized device is exposed to ethylene oxide gas at 65 ° C. for about 1 hour to 30 ° C. for about 4 hours. Dry heat sterilization generally involves exposing the sterilized device to a temperature of about 180 ° C. or higher for at least 2 hours.

In many environments, the effectiveness of the sterilization cycle is important. Therefore, the effectiveness of the sterilization cycle is determined using the sterility indicator.

[0006] Sterility indicators have taken many forms in the past. For example, biological and chemical indicators are well known in the prior art. With conventional biological indicators, a test organism that is many times more resistant to the sterilization process than most organisms that are present due to natural contamination is applied to the support and reduced with the sterilized product. Place in the fungus. Thus, the sterility indicator is exposed to the same sterilization cycle as the device to be sterilized. After the sterilization cycle is completed, the support is cultured in a nutrient medium to determine how much of the test organism is alive following the sterilization procedure. It generally takes at least about 24 hours for a detectable number of organisms to grow.

Next, the sterility indicator is examined to determine if such growth has occurred. If growth did occur, such growth would indicate that the sterilization cycle was not effective, and devices exposed to the sterilization cycle would not be sterile.

[0008] Commercially available chemical indicators use chemicals that exhibit sterility by a change in color or change from solid to liquid. One advantage of these chemical indicators is that the results are known at the end of the sterilization cycle. However, the results only indicate that, for example, a certain temperature has been reached during a period of time, or that ethylene oxide gas was present during the sterilization cycle. Chemical indicators do not indicate whether the conditions necessary to eliminate the organism in question have been achieved. Accordingly, the industry has favored biologically based biological indicators.

[0009] Another prior art biological indicator is disclosed by Matner et al. (US Pat.
18, 167). Matner et al. Describe a biological indicator comprising a spore strip in which a vial made of flexible polypropylene has a viable distribution of bacterial fatty thermophilic spores (Bacillus Stearoth thermophilus). The vial further comprises a growth medium, which is a denatured latent soy medium contained in a breakable glass ampoule. The presence of a spore-related enzyme, α-glucosidase, indicates spore growth in a biological indicator. The presence of α-glucosidase is measured on a non-fluorescent support, ie, 4-methylumbelliferyl-α-D-glucoside. The non-fluorescent support is converted to a fluorescent product by the active spore-related enzyme.

When the sterilization cycle is not effective, both the spores and the enzyme remain active. The enzyme converts the support to a fluorescent product. Therefore, after the culture period, the fluorescence in the vial is detected to determine the effectiveness of the sterilization cycle.

Although Matner et al. Represent a significant advance in the prior art, the biological indicator reading system described in Matner et al. Has a number of disadvantages. The system of Matner et al. Is configured to read only one biological indicator at a time. Thus, the operator places the biological indicator (BI) in one heater, which is set to heat the biological indicator to one set temperature. The operator then sets a timer. When the timer stops, the biological indicator is removed from the incubator (or heater) and placed in one read cell as described in Matner et al. A fluorescence reading is taken for the biological indicator to determine if spore growth activity is indicated by the biological indicator (and therefore whether the sterilization cycle to which the biological indicator was exposed was effective)
Is provided to the operator.

[0012] Treating BI in this manner is a cumbersome system to track a large number of biological indicators. First, since this system has only one incubator that heats to one temperature, reading a different type of biological indicator requires the use of a separate biological indicator reader. (That is, the biological indicator must be cultured at another temperature at another time). In addition, the user has to
The time at which I was placed in the incubator is charted separately, the duration of each BI cultivation is tracked, and the results of each BI reading step are recorded, indicating the effectiveness of each associated sterilization cycle Must be represented graphically. In addition, the operator has one B
To read the fluorescence from I, the BI must be processed several times. The operator must place the BI in the incubator and remove the BI when a reading is needed. Then, if further culturing or reading is required, the operator must again place the BI in the incubator and read it again after removing the BI.

[0013] Further, in the system of Martner et al., The fluorescence sensor is configured to sense fluorescence emitted from one small point on the biological indicator container. Thus, the fluorescence activity is sensed only from a portion of the BI, not from the entire periphery of the BI. A signal is generated based on the small amount of fluorescence detected. As a result, a relatively small amplitude sensor signal is generated, and the generated sensor signal must be greatly amplified to obtain a signal that can be further processed with a desired amplitude.
However, the required amplification causes significant errors in the sensor signal and also reduces the signal-to-noise ratio corresponding to the fluorescent signal.

DISCLOSURE OF THE INVENTION The apparatus reads a plurality of biological indicators contained in a biological indicator container (the biological indicator and the container are collectively referred to as BI) and determines the effectiveness of a plurality of sterilization cycles. I do. Each BI exhibits a fluorescence corresponding to biological activity indicative of bacterial growth in the container. The plurality of BI holders are configured to receive one BI each. The carriage is controllably movable with respect to the plurality of BI holders to a position close to each BI holder. The radiation emitter is mounted on the carriage and the selected BI
It is arrange | positioned so that radiation may collide with BI accommodated in the holder. A fluorescence sensor is also mounted on the carriage and positioned so that the BI in the selected BI holder senses the fluorescence indicated in response to the radiation. The controller is coupled to the fluorescence sensor and receives the fluorescence signal and sends an output signal indicative of the sensed fluorescence. The controller is configured to control the position of the carriage and intermittently position the carriage in proximity to each BI holder currently holding the BI. The memory is coupled to the controller and is configured to receive and store data indicating the fluorescence of each BI based on the fluorescence signal received by the controller.

In a preferred embodiment, the carriage is provided with a second controller, which processes the signals transmitted by the fluorescent sensors and provides the fluorescent signals to the first controller. In another preferred embodiment, a plurality of separately controllable heaters are provided so that one system can culture and read various types of biological indicators.

In yet another preferred embodiment, integrated cavities are provided around each BI in the incubator. This integrated cavity collects the fluorescence from most of the outer portion of the BI and directs the fluorescence to the fluorescence sensor. This corrects for non-uniformities. In addition, a sensor signal is generated that has a relatively high amplitude, a relatively high error strength, and requires relatively little amplification.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 is a perspective view of one embodiment of a biological indicator (BI) reader 10.
The BI reader 10 includes a housing 12 having a plurality of BI receiving recesses 14. Each receiving recess 14 has a display associated with a display panel 16. Further, operator interaction is performed using any scroll buttons 18 and operator display 20. FIG. 1 shows one of the BI receiving recesses 14.
The BI 22 that is present in each case is shown. FIG. 1 further shows a cover 24 pivoted substantially along an arc 26 to alternately expose and cover the BI receiving recess 14.

In the embodiment shown in FIG. 1, BI receiving recesses 14 are arranged in two groups. The first group is associated with the first culture area 28 and the second group is associated with the second culture area 30. As described in detail later in this specification, the first culture region 2
8 relates to a first heater for heating the corresponding BI receiving recess 14 to a first temperature. The second culture zone region 30 is associated with a second heater that heats the corresponding BI receiving well 14 to a second temperature. Thus, multiple types of biological indicators can be received simultaneously. Further, as will be described in detail later in this specification, the housing 1
0 includes circuitry to read substantially all biological indicators.

In a preferred embodiment, the biological indicator support and corresponding container (collectively, BI) are provided by Minnesota Mining an, St. Paul, Minn.
d A biological sterility indicator marketed by the Manufacturing Company as 3M ATTEST, model 1291 or 1292. B
I22 includes a lid, a vial, and various contents (not shown). BI22 demonstrates the presence of viable microorganisms (such as spores) by producing fluorescence in vials after being cultivated in one of the culture regions 28 and 30. This is accomplished by using a non-fluorescent support (such as 4-methylumbelliferyl-α-D glucoside) in the vial and converting the non-fluorescent support to a fluorescent product by the activity of a spore-related enzyme. preferable. The spore-related enzyme is preferably α-D-glucoside, which is one of the enzymes involved in spore growth in a vial.

In operation, the operator first retrieves the biological indicator 22. This biological indicator must be read in culture. The operator then destroys the ampoule (not shown) in BI 22 and places BI 22 in the appropriate BI receiving recess 14. The operator can then use the scroll buttons 18 and observe the display 20 to program the culture area 28 or 30, or
Culture areas 28 and 30 can be configured prior to placing 2 in BI receiving well 14.

In any case, the operator closes the cover 24 after configuring the culture area,
It is only necessary to wait for a positive or negative indication to be displayed on the display panel 16 of the relevant biological indicator contained in the BI 22. Since substantially all of the fluorescent reading circuitry is contained within the housing and is configured to read the BI22 while the BI22 is in the BI receiving recess 14, the number of steps required by the operator and prior art BI readings The cumbersome aspects of the device are substantially reduced.

FIG. 2 shows a more detailed block diagram of the biological indicator reader 10 shown in FIG. Parts similar to those shown in FIG. 1 are indicated by similar reference numerals. BI reader 10 includes a microprocessor 32 that includes an associated athletic response memory 34 and a programmable memory 36. The reading device 10 includes a display 16, a multiplexer 38, operator input and displays 18, 20 (collectively referred to as an operator interface 19), a step motor controller 40, a stepper motor 42, a driving mechanism 44, a fluorescent sensor circuit 46, and a first heater 48. , A second heater 50, a plurality of BI presence sensors 52, and a multiplexer 54.
Also, in the preferred embodiment, microprocessor 32 is asynchronously coupled to communicate with other systems or servers.

In the preferred embodiment, microprocessor 32 is a suitable microprocessor or microcontroller that is programmed to control the desired operation. Microprocessor 32 comprises an integrated timing device or a BI
Preferably, a separate timer circuit is provided for timing in the circuitry of the reader 10. Program memory 36 is preferably a read-only memory that is integrated with or associated with microprocessor 32. Memory 34 is preferably random access memory (RAM) or any other memory suitable for storing data received by microprocessor 32 and reflecting the kinetic response of the BI during the fluorescent reading operation.

The stepper motor 42 and the step motor controller 40 are preferably conventional products that are commercially available. The drive mechanism 44 is preferably a linear drive mechanism, described in detail with respect to FIG. 4, or a rotary drive mechanism, described in detail with reference to FIGS.

The heaters 48 and 50 are preferably programmable heaters that can be configured to heat to various temperatures. Also, heaters 48 and 50 preferably have an associated thermistor that senses the temperature and sends a feedback signal to microprocessor 32 so that closed loop control of heaters 48 and 50 occurs. In one preferred embodiment, heater 48 is configured to heat up to 60 ° C, while heater 50 is configured to heat up to 37 ° C. Heaters 48 and 5
0 is connected to BI receiving recess 14 by a highly thermally conductive material. Accordingly, heater 48 heats the associated group of BI receiving depressions 14 to about 60 ° C, and heater 50 heats the associated group of BI receiving depressions 14 to about 37 ° C.

The BI presence sensor 52 is preferably an infrared detector. In one preferred embodiment, a BI presence sensor 52 is associated with each BI receiving recess 14. BI presence sensor 52 is configured to detect the presence of BI 22 in the associated BI receiving recess 14. The BI presence sensor 52 is further coupled to the microprocessor 32 via a multiplexer circuit 54.

The fluorescent sensor circuit 46, in one preferred embodiment (and as described in more detail with respect to FIG. 3), is equipped with a flash mechanism and a fluorescent sensor. Fluorescence sensor circuit 46 is mounted on a carriage assembly, also described in detail later herein, to move relative to DI receiving recess 14. In a preferred embodiment, the fluorescence sensor circuit 46 is movable within a position proximate to each of the DI receiving recesses 14 and is capable of reading the fluorescence readings from the DIs 22 received within the DI receiving recesses 14.

The DI 22 is first placed in a sterilizer along with other devices or equipment to be sterilized. Next, a sterilization cycle is performed. The sterilization cycle generally involves steam sterilization, dry heat sterilization or chemical or radiation sterilization techniques. Different time frames, thermal regimes and sterilization cycles require the use of different types of BIs, as is well known. In each case, DI22 is exposed to a sterilization cycle.

The operator may then, in one preferred embodiment, tell the reader 10, preferably via the operator interface 19, a particular type of D to use as the DI 22.
Enter I20. That's a lot to do. First, the specific type of
The DI indicates to microprocessor 32 the exact set point of heater 48 or 50 associated with DI receiving depression 14 in which DI 22 is located. For example, one type of BI needs to be cultured at about 60 ° C and another type of BI needs to be cultured at about 37 ° C. Naturally, the heater can also be easily pre-configured by the operator. In either case, the microprocessor 32 preferably controls the heater to a desired set point with closed loop control.

Further, based on the type of DI used, the microprocessor 32 retrieves relevant fluorescent motion behavior information to use when transmitting the validity output. This kinetic information preferably indicates the fluorescent behavior of a particular BI under conditions where the sterilization cycle to which the BI was exposed was and was not effective.

Next, conditions for BI 22 are determined so that spores grow. In an embodiment where BI 22 is implemented as a 3M AT TEST model 1291 BI, the glass ampoule containing the growth medium is broken and the contents are applied to a dry strip containing the spores.
Next, the BI 22 is prepared to be cultured and placed in the cavity 14.

The microprocessor 32 communicates via a multiplexer 54 with a BI presence sensor 52
Read the indicated value periodically from. In any of the BI presence sensors 52, the BI
If the microprocessor 32 does not send a signal indicating that it is within, the microprocessor 32 simply continues to read from the sensor 52 intermittently. If the operator places the BI 22 in the recess 14 but has not yet received a signal from the sensor 52, the operator places the BI 22 in the BI
It is likely that the receiving recess 14 is not completely received. In this case, BI22
Does not receive complete heat from the corresponding heater 48 or 50, and therefore does not perform proper culturing. In addition, if the BI 22 is not completely received in the BI receiving well 14, it is not in the proper position where an accurate fluorescence reading can be read. Therefore, the operator can determine that BI 22
After the microprocessor 32 has been instructed that it is not completely contained in the receiving recess 14, corrective action can be taken to fully receive the BI 22 in the BI receiving recess 14.

The microprocessor 32 receives a signal from one BI presence sensor 52 that the BI 22 has been received in the BI receiving recess 14 and then sends a plurality of fluorescence readings to that B
Control the circuit to read from I22. The microprocessor 32 first sends an output to the stepper motor controller 40 so that the stepper motor 42
The drive mechanism 44 is operated so that the fluorescence sensor circuit 46 is arranged at a position close to the BI receiving recess 14 where the BI 22 exists. The microprocessor 32 then controls the fluorescence sensor circuit 46 to read a plurality of fluorescence instruction values from the BI 22.
The result of the fluorescence reading is sent to the microprocessor 32 and stored in the exercise response memory 34 by the microprocessor 32.

In the preferred embodiment, the motion response memory 34 is divided into blocks, one block associated with each BI 32 currently processed. That block of the exercise response memory now contains data indicating a plurality of fluorescence readings for a particular BI 22 over time. This exercise data is processed by the microprocessor 32 and sent to the display panel 16 as an output indicating whether the sterilization cycle associated with this particular BI 22 was effective.

A specific method of reading an indication is described in US patent application Ser. No. 08 / 856,104, filed May 14, 1997, and assigned to the same assignee as the present application, “SYSTE.
M FOR MEASURING THE EFFICACY OF A STERI LIZATION CYCLE "(a system for measuring the effectiveness of a sterilization cycle) can be implemented in a number of ways. Briefly, after placing the BI 22 in the receiving recess 14, the operator indicates, via the operator interface 19, the type of BI to be used. The microprocessor 32 then checks in the program memory 36 or the exercise response memory 34 for the corresponding exercise behavior information to be used to deliver the validity output. It is preferable that the exercise behavior information is information indicating a fluorescence indication value corresponding to an effective and ineffective sterilization cycle for a specific type of BI.

Next, at approximately time 0 (before significant cultivation), but after the glass ampule has been broken (ie, after wetting the BI), the first fluorescence reading is read. This fluorescence reading indicates the current autofluorescence behavior of the particular BI 22 from which the reading was taken. Furthermore, unless the BI22 is contaminated prior to the sterilization cycle, the first fluorescence reading does not include fluorescence due to significant spore growth.

The microprocessor 32 then compares the first fluorescence indication value with a predetermined threshold level stored in the exercise response memory 34. If the first reading exceeds this threshold level, this indicates that the particular BI 22 from which the first reading was read was contaminated, such as at the manufacturer of that particular BI 22, prior to the sterilization cycle. . That is, if BI22 is contaminated prior to the sterilization cycle, significant spore growth or bacterial activity has already occurred within the BI22 prior to culture. Thus, the initial first fluorescence reading reflects a higher degree of fluorescence than the autofluorescence behavior expected from uncontaminated BI. Therefore, when the microprocessor 32 determines that the first fluorescence indication value read from the BI 22 exceeds the threshold, the particular BI 22 from which the indication value was read is contaminated and cannot determine the effectiveness of that particular sterilization cycle. Is output to the operator interface 19.

If the BI 22 was not contaminated, the microprocessor 32 would read a number of readings to look for a local minimum of the motor response information associated with that particular type of BI, Is preferably controlled. The fluorescence indication value read at this time corresponds to the reference fluorescence indication value of the specific BI 22 to be read.

The reference fluorescence reading is read by microprocessor 32 and stored in a corresponding portion of motion response memory 34 associated with that particular BI 22. The initial or reference fluorescence reading indicates the autofluorescent behavior of the particular BI 22 from which the reading is read.
Further, if BI 22 was not contaminated prior to the sterilization cycle, the reference or threshold reading would not include fluorescence due to significant spore growth.

After reading the reference indication value, the microprocessor 32 waits for a specified timeout. The length of the timeout will correspond to the particular BI used and at what rate the spore growth activity is expected to occur. Such a timeout may be, for example, 1 to 3 minutes or more as necessary.

During a predetermined timeout, the microprocessor 32 can perform other predetermined operations. For example, the microprocessor 32 arranges the fluorescence sensor circuit 46 in close proximity to another BI receiving recess 14 and reads a fluorescence indication value from another BI 22. The operator of the system 10 may read the BI 22 at any time into the
Since the BI 22 can be arranged asynchronously with the microprocessor 22, the BI 22 can be cultured and processed asynchronously by the microprocessor 32. Therefore, during the timeout period, the microprocessor 32 preferably performs other operations related to the processing of the other BIs 22.

After a predetermined timeout, another fluorescence reading is read from the particular BI 22.
The microprocessor 32 reads the secondary fluorescence indication value from the BI 22,
The movement response memory 34 is read for the fluorescence reading and for that particular BI 22.
Is compared with the reference fluorescence stored in. If the microprocessor 32 determines that the second fluorescence indicator exceeds the reference fluorescence indicator by a statistically significant amount, this indicates that a statistically significant amount of biological activity, i.e., spore growth, Within the culture cycle. Thus, the sterilization cycle was not effective. Accordingly, the microprocessor 32 sends an output to the display panel indicating that the sterilization cycle was not valid.

If the spore growth rate determined in the analysis for a particular BI 22 does not exceed the reference fluorescence reading by a statistically significant amount, the microprocessor 32 determines whether additional culture time is required. The biological indicator is cultured anywhere between 5 to 15 minutes or more. However, using the system of the present invention to read BI22, the effectiveness of the sterilization cycle can be determined after only a few minutes for biological indicators, and in less than 10 minutes for a very large number of biological indicators, Less than 15 can be determined for virtually all biological indicators of this type. The operator may use a microprocessor to incubate the biological indicator for a period of time sufficient to achieve an appropriate confidence level that the specific DI22 has no spore growth activity and no subsequent spore growth activity. You only need to program 32. This time is preferably determined by an experimental investigation of the characteristics of the various BIs to be analyzed.

The microprocessor 32 determines that the secondary fluorescence indicator did not exceed the reference fluorescence indicator by a statistically significant amount and determined that no additional culture time was required,
An output is sent to the operator via multiplexer 38 and display panel 16 indicating that the sterilization cycle was effective.

FIG. 3 is a more detailed block diagram of the fluorescence sensor circuit 46. The circuit 46 is
It includes a photoelectric module 60, a photoelectric sensing module 62, a reference module 64, and a microprocessor 65. FIG. 3 further shows the associated DI 22 and DI receiving recess 14, with the fluorescent sensor circuit 46 located in close proximity thereto.

To read the fluorescence reading from the DI 22, the photoelectric module 60 provides the fluorescent support and reference module 64 in BI 2 522 with the optical signal. The photovoltaic module 60 preferably includes a toki mechanism 66 and a filter 68. The toki mechanism 66 is, in one preferred embodiment, a flash tube, such as a xenon flash tube, that emits a rich broadband light pulse (eg, a 100 μs pulse) in the near ultraviolet range of wavelengths. In another preferred embodiment, the Toki mechanism 66 is a cold cathode fluorescent lamp (CCFL), which provides a continuous wave source, such as a phosphorescent mercury arc lamp, and is available from JKL, Inc. of Pacoima, California. . Is commercially available. Other suitable toki mechanisms may be used.

The filter 68 may be a part of the mechanism 66, and is preferably a glass filter that exhibits low autofluorescence and absorbs a selected wavelength. Suitable filters are available from Schott Glass Technology, Duria, PA.
gies, Inc. Are commercially available Schott BG39 and UG11.
Light passes through filter 68 and strikes DI 22 and reference module 64. If the mechanism 66 is a CCFL, then filtering is also needed to filter out sideband light.

The reference module 64 preferably includes a reference light sensor and a filter (not separately shown). The filter is preferably a single filter or a collection of filters, preferably selected to pass the pulsing energy passing through filter 68. A filter in module 64 sends this energy to a reference light sensor included in module 64. Suitable filters are available from Schott Glass Technologies, Inc. of Duria, PA. Are commercially available Schott BG39 and UG11.

A reference light sensor in module 64 senses the energy passing through the filter and sends a reference signal to microprocessor 65 indicating that the energy has passed through the filter in module 64. Therefore, the reference signal transmitted to the microprocessor 65 indicates the intensity of the toki energy emitted by the toki mechanism 66.

Light that passes through the filter 68 and collides with the DI 22 irradiates the fluorescent substance in the DI 22. The fluorescence expressed by DI 22 is preferably collected by an integrated cavity in DI receiving cavity 14, which collects (or collects) the fluorescence expressed by BI 22 and directs the fluorescence to photoelectric sensing module 62. Preferably, it is a geometrically reflective cavity (such as a parabola, hyperbola or sphere) positioned around the BI 22 to orient.

The photoelectric sensing module 62 includes a filter 70 and an optical sensor 72. The filter 70 is a single filter or a set of filters.
Preferably, it is selected to reject surface reflections from the BI22 surface when impacting the I22 surface. Suitable filters block light in the approximately 350 nm wavelength range and pass light in the approximately 450 nm wavelength range. Any suitable filter that helps reduce the interference between the toki energy from the Toki mechanism 66 and the fluorescence development energy from the BI 22 can be used. This filter acts to pass an expression wavelength that exhibits fluorescence in BI 22. One suitable filter for use as the filter 70 is Schott Glass Technologies, Inc. Are commercially available as Schott BG39, KV408 filters. The output of the filter 70 is sent to the optical sensor 72. The optical sensor 72 is 400 to 450 n
A blue-enhanced photodiode that enhances the sensitivity of the photodiode in the m wavelength range is preferred. One suitable optical sensor 72 is Bu, Taxon, Arizona.
rr Brown Corporation is commercially available under the trademark OPT301.

The output of the optical sensor 72 is sent to the microprocessor 65. In a preferred embodiment, the microprocessor 65 receives the output from the associated memory, the timed circuit, the amplifier, and the modules 62 and 64 to indicate the intensity of the toki 66 and the fluorescent activity within the BI 22, respectively. And any other suitable adjustment circuit suitable for sending its output as an adjustment signal. More preferably, microprocessor 65 includes a connection that connects to microprocessor 32 via a flexible circuit or other suitable circuit.

By equipping both the reference sensor module 64 and the optical sensor 72,
Many things can be done. First, the energy (light pulses, etc.) supplied by the toki mechanism 66 is not completely constant from flash to flash in embodiments where the toki mechanism 66 is a flash tube. That is, the light output from the toki mechanism 66 depends somewhat on the temperature of the plasma arc in the lamp. Thus, flashes may exhibit some variation in spectral content from flash to flash. If the first flash is directed at the BI 22, the fluorescence activity is one level, but if a second flash, which is more intense than the first flash, is directed at the same BI 22, the fluorescence behavior of the material within the BI 22 will be different. By equipping a reference light sensor, the signal representing the fluorescent energy developed by BI 22 can be normalized using a particular reference signal from reference module 64 indicating the intensity of a particular flash from mechanism 66. . Thus, by altering the effect of the various storm intensities, subsequent processing steps are substantially eliminated.

Further, the intensity of light from the toki mechanism 66 tends to decrease with time, and the toki mechanism 66 eventually stops operating. By including a reference module 64 configured to sense the intensity of the energy from the toki mechanism 66, the microprocessor 65 sends a signal to the microprocessor 32, which causes the microprocessor 32 to The operator interface 19 can be used to notify the operator when the mechanism 66 fails to operate sufficiently.

Further, the reference module 64 is advantageous when used in conjunction with the BI presence sensor 52. If the BI presence sensor 52 indicates that the BI is at a predetermined location within the cavity 14, the microprocessor 32 determines whether the particular cavity 14 is dirty or requires cleaning or other work. Can be determined. For example, if BI 22 is not located in depression 14, microprocessor 32 expects that some type of autofluorescent behavior will occur corresponding to a flash from flash mechanism 66. Also, the reference module 64 is configured to receive the onset energy reflected from the indentation 14 rather than directly from the filter 68, and the microprocessor 32 controls the expected result of the flash (or toki) and the actual result of the flash. Compare the results to see if there is any foreign material in the depression 14, whether the wall of the depression 14 is covered with debris or not, if it needs to be cleaned, or if the depression 14 has any other You can determine if you need work.

FIG. 4 is a partially exploded view of a part of the reading device 10 with the housing 12 removed. FIG. 4 better illustrates the configuration of a preferred embodiment of the drive mechanism 44. Parts similar to those shown in FIGS. 1 and 2 are indicated by similar reference numerals. FIG. 4 shows that the fluorescence sensor circuit 46 is mounted on a pair of linear slides 74 and 76. FIG. 4 further illustrates that the BI receiving recess 14 has an opening 73 therein.
Opening 73 exposes the lower portion of BI 22 to fluorescence sensing circuit 46. Slides 74 and 76 are disposed substantially parallel to each other, mounted on opposing brackets 75 and 77, extend along the plurality of BI receiving recesses 14, and have openings 73.
Are located in close proximity to the portion of the BI receiving recess 14 that is opposed to. Further, a second opening (ie, a passage) is formed in the BI receiving recess 14 so as to substantially face the opening (ie, the passage) 73. BI presence sensor 52 is preferably an infrared sensor that includes both an infrared emitter and an infrared detector. The presence sensor 52 is disposed adjacent the second opening of the BI receiving recess 14, as shown in more detail with respect to FIG.
An infrared emitter is capable of impinging infrared radiation on the BI receiving recess 14 via the second passage. If infrared radiation is reflected back, this indicates that BI 22 is located in BI receiving recess 14 and presence sensor 52 is sending the appropriate output to microprocessor 32. However, if the expected amount of infrared is not reflected back, the infrared detector will not sense the appropriate level of reflected infrared. This is BI
No. 22 is not present in the particular BI-receiving recess 14. Again, the particular presence sensor 52 sends an appropriate signal to the microprocessor 32 indicating that BI 22 is not present.

FIG. 5 better illustrates the configuration of heaters 48 and 50 in a preferred configuration according to the present invention. In one preferred embodiment, the BI receiving recess 14 is preferably defined by or located adjacent to blocks 92 and 94 of thermally conductive material. The heaters 48 and 50 are commercially available resistive elements or other suitable heating devices, and are highly thermally conductive connections (such as screws or other suitable connection devices) that bring the heaters 48 and 50 into integral contact with the blocks 92 and 94. Connection to the blocks 92 and 94, or by using a highly thermally conductive intermediate mechanism.

The conductors 96 and 98 are connected to the heaters 48 and 50, respectively. Conductor 9
6 and 98 are also connected to the power and control circuitry of a conventional heater, and are thereby controlled by the microprocessor 32. The heater power and control circuit supplies power to the heaters 48 and 50 via conductors 96 and 98 to heat the heaters 48 and 50 under the control of the microprocessor 32. Heaters 48 and 50
Are also equipped with thermocouples, thermistors or other suitable heat sensing devices, which are in close proximity to heaters 48 and 50 or heat conductive blocks 92 and 94.
The heat sensing device is further electrically coupled to the microprocessor 32. The heat sensing device
A signal indicative of the heat of the thermally conductive blocks 92 and 94 is transmitted to the microprocessor 32 so that the microprocessor 32 can operate in a closed loop manner with the heaters 48 and 5.
0 can be controlled.

FIG. 5 illustrates an intermediate bracket 1 with five suitable fasteners, such as screws 104.
Via blocks 00 and 102, blocks 92 and 94 are connected to brackets 75 and 7
It is further indicated that it is preferred to couple to 7 (or other suitable structural support portion of housing 12). In the preferred embodiment, brackets 100 and 102
Is made of a material having a very low thermal conductivity compared to the blocks 92 and 94. Further, in a preferred embodiment, blocks 92 and 94 are spaced apart from each other by air gaps or sufficiently insulative materials to heat one of blocks 92 and 94 to a different temperature. Is not significantly heated by the heater associated with the other of blocks 92 and 94. In this way, strict heating management can be maintained throughout blocks 92 and 94.

FIG. 6 illustrates one preferred arrangement and configuration of the BI 22 and various components of the device 10 relative to the housing 12. FIG. 6 illustrates that in one preferred embodiment, the BI presence detector 52 is located in a portion of the housing 12 forward of the BI 22,
The fluorescent sensor circuit 46 and its associated slide, motor and belt drive
Although shown to be located on the rear portion of the housing 12 relative to the BI 22, it is understood that other suitable configurations may be used.

FIG. 7 shows one preferred arrangement of the presence sensor 52, the BI receiving well 14 and the fluorescence sensor circuit 46 on a greatly enlarged scale. FIG. 7 shows the second passage 106 through the wall of the BI receiving recess 14. The passage 106 is located at the bottom of the recess 14, and the BI presence sensor 52 is located close to the passage 106. Thus, presence sensor 52 sends a signal to microprocessor 32 indicating that BI 22 is not present in depression 14 unless BI 22 is completely and correctly received in depression 14 toward the bottom of depression 14.

FIG. 7 further illustrates any one configuration of BI 22. In one preferred embodiment for reading BI 22, fluorescence sensor circuit 46 includes a BI container 22 facing circuit 46.
Read the fluorescence reading based on the fluorescence expressed from a small portion of the surface of. in this case,
It is important that BI 22 maintain the same orientation within recess 14 for subsequent readings. Therefore, in one preferred embodiment according to the invention, the BI 22 is equipped with a lid 23 having an anti-rotation mechanism 25. The anti-rotation mechanism 25 is, in one preferred embodiment, a simple tab or protrusion extending away from the surface of the lid 23.
Indentations 14 are also formed to define cuts for receiving the protrusions. Therefore, the direction of the angle of the BI 22 around the longitudinal axis is such that the BI 22
4 must be identical so that they are completely received and fitted. Thus, each time circuit 46 subsequently reads BI 22, the angular orientation of BI 22 is substantially the same.

However, in another preferred embodiment, at least in the area of the passage 73,
The walls of the depressions 14 extending around the perimeter of substantially the entire BI 22 in that region are formed from a reflective material having a geometry that helps the BI 22 reflect the fluorescent light emerging in the direction of the passage 73. . One such geometry is part of a parabola, while the other geometry may be part of a sphere. Other suitable geometries may be used. In this case, the fluorescent light that is developed on substantially the entire outer periphery of the BI 22 in the area of the passage 73 is collected or collected and sent to the light sensor in the circuit 46. Therefore, it is not important that the lid 23 has the rotation preventing mechanism 25.

In any event, whether or not the circuit 46 reads fluorescence only from a small portion outside the BI 22, or reads fluorescence reflected from around the entire outer periphery substantially below the BI 22. Instead, the circuit 46 is preferably equipped with a circuit board 198 on which the photoelectric reference module 64 and the photoelectric sensing modules 62 and 64 are mounted. FIG. 7 shows a preferred embodiment for mounting modules 62 and 64. The module 64 faces the Toki mechanism 66, but the filter 6 of the Toki mechanism 66
8 is preferably attached to the back side of the circuit board 108 with respect to the BI 22 so as to be located on the opposite side of the circuit board 8. In addition, module 62 may be
It is preferable to attach the circuit board 22 to the front side of the circuit board 108. Thus, the photovoltaic reference module 64 is arranged to easily receive the uplift energy from the lamp 66 after passing through the filter 68, but substantially prevent it from receiving the fluorescence manifestation energy from the BI 22. Similarly, the photoelectric sensing module 68 includes
It is arranged so that it does not directly receive the energy from the BI mechanism 66 but easily receives the expression energy from the BI 22. Naturally, as described above, module 6
2 and 64 preferably comprise both a photoelectric sensor circuit and a filter suitable for enhancing the sensing of the desired wavelength.

FIG. 8A is a top partial cross-sectional view of the block 92, showing the BI presence sensor 52, BI
3 shows the arrangement of the receiving recess 14 and the fluorescence sensor circuit 46. Similar parts are denoted by similar reference numerals to those shown in the previous figures. FIG. 8A further illustrates one preferred embodiment of the shape of the BI receiving recess 14 in the passage 73. BI receiving hollow 14
Is shown defined by walls 110 in this region. The wall 110 is preferably comprised of a mirrored material or other suitable reflective material, and is configured in a hemispherical shape or a shape corresponding to another part of a sphere. FIG. 8A shows the BI 22 located at the base of the spherical portion of the depression 14. However, the BI 22 may be located in another area of the depression 14, such as at a position slightly away from the base of the spherical wall of the depression 14.

FIG. 8B is a greatly enlarged view of another arrangement of BI receiving recess 14 and circuit 46 according to the present invention. Similar parts are denoted by similar reference numerals to the parts shown in FIG. 8A. In FIG. 8B, depression 14 indicates that wall 110 is constructed from a reflective material and is configured as part of a parabola. The BI 22 is spaced apart from the base of the parabolic portion, and is arranged so as to be centered on one focal point of the parabola. Further, FIG. 8B shows that the thrust mechanism 66 in the circuit 46 is received in the room defined by the wall 112. The wall 112 is substantially parabolic and the wall 110
Is configured as a parabolic portion that substantially completes the parabolic portion of Toki Mechanism 66
Is preferably located at the other focal point of the parabola, spaced from the base of the parabolic portion defined by wall 112 and opposite the focal point of the parabola where BI 22 is located. Many other suitable shapes, such as ellipses, complex curves, or other suitable shapes or contours, can be used as indentations.

FIG. 9 is a top view of another preferred embodiment embodying a biological indicator reader according to the present invention. FIG. 9 shows the reading device 114. The reader 114 is equipped with four culture areas 116, 118, 120 and 122. Each culture area has a plurality of BI-receiving depressions 14 therein.

Since there are four culturing areas, the reading device 114 needs to use different culturing temperatures.
4 so that it can be configured to heat to 4 different temperatures to accommodate the type of BI
Equipped with two heaters. Preferably, portions of the culture area are identified with a color that matches the color of the lid, depending on the particular type of BI used. The operator can arrange the BI 22 in an appropriate culture area and perform appropriate culture only by matching the color of the lid of the BI 22 with the color of the culture area.

The culture areas 116, 118, 120 and 122 are arranged annularly around a centrally located rotatable reading turret 124. The reading turret 124 includes a fluorescence sensor circuit 146. Each reading recess 14 has a corresponding BI presence sensor 5
2 As soon as the operator places the BI 22 in one of the depressions 14, the reading turret 124 is intermittently moved to a position where the fluorescence sensor circuit is located close to the BI receiving depression 14 and the reading of the fluorescence can take place. . In the preferred embodiment, the angular position of the reading turret 124 is tracked and maintained by the microprocessor 32. Thus, the reading turret 124 can rotate in a circular direction in the opposite direction to approach the various reading recesses 14 in the culture areas 116, 118, 120 and 122. The microprocessor 32 preferably controls the reading turret 124 to prevent the reading turret 124 from rotating beyond 360 ° or another suitable arc to prevent the flex circuit 86 from twisting or tangling.

FIG. 10 is a side sectional view of a part of the reading device 114. FIG. 10 shows that the stepper motor 42 is preferably located at the bottom of the reading turret 46 and its drive output 78 is preferably coupled to the reading turret 46. Therefore, the microprocessor 3
2 controls the stepper motor 42 to approach one of the passages 73 associated with the reading recess 14 where the BI 22 is located.

FIG. 10 further illustrates another embodiment of a BI presence sensor 126. FIG.
The presence sensor 126 shown in FIG.
Is provided. The drive rod 120 has a first end 132 that projects into the recess 14 beyond the bottom surface of the recess 14. Rod 128 is preferably biased to an upwardly projecting position by a spring or other suitable biasing member (not shown). When the operator correctly receives the BI 22 in the recess 14, the bottom portion of the BI 22 contacts the upper portion 130 of the drive rod 128 so that the drive rod 128 is lowered to a lower position and pushes the switch sensor 130. Next, the switch sensor 130 sends a signal indicating that the BI 22 is present in the specific recess 14 to the microprocessor 3.
Send to 2. FIG. 10 shows a serial port 134, which is preferably coupled to the microprocessor 32 for communicating asynchronously with other devices, such as a server, as described with respect to FIG.

FIG. 11 shows another preferred configuration of the recess 14. Recess 1 shown in FIG.
4 is similar to BI receiving recess 14 shown with respect to the previous figure, but with passage 73 in FIG.
1 in that it is formed at the bottom of the recess 14 shown in FIG. Therefore, the reflection surface 110 shown in FIG. 11 is made of a reflective material, and is a surface that reflects the fluorescence generated by the BI 22 downward in the direction of the fluorescent sensor circuit 46, and the fluorescence generated by the BI 22 is the BI surface.
Instead of being lateral to 22, it is collected and collected downward through passage 73 and directed. Of course, the reflective surface may be configured with any suitable geometric shape.

FIG. 12 shows another preferred embodiment of the arrangement of the sensor modules 62 and 64. Similar parts are denoted by similar reference numerals to the parts shown in the previous figures. FIG.
7 is similar to that shown in FIGS. 7 and 8B where the fluorescence expressed by BI22 is directed laterally with respect to BI22, but the fluorescence expressed by BI22 is downward with respect to BI22. Figure 1 expressed in 46 directions
The type shown in FIG. In any case, modules 62 and 64
Rather than being located on the opposite side of the printed circuit board or other support member 108, it is located outside and away from the direct path of radiation from the tow mechanism 66. Thus, the sensor does not prevent impact photons from hitting the target.

Instead, the dichroic reflector 36 is positioned with respect to the thrust mechanism 66 and the passage 73 so that light of different wavelengths is reflected in different modules 62 and 64. In a preferred embodiment, dichroic reflector 136 is configured to direct a portion (preferably about 4%) of the storm radiation from storm mechanism 66 toward module 62. The dichroic reflector 136 is also preferably configured to direct emission radiation (ie, fluorescence radiation) from the BI 22 toward the module 64. Therefore, the dichroic reflector 136 preferably directs a portion of the toki frequency, typically on the order of 350 nm, toward the module 62 so that the module 62 can transmit a predetermined reference signal. Dichroic reflector 1
More preferably, 36 directs emitted radiation, on the order of about 450 nm, toward sensor module 64 such that module 64 can sense the fluorescence developed by BI 22 and transmit the desired sensor signal. Other suitable configurations may be used.

In any of the above embodiments, the operator destroys the ampoule in BI 22 before placing BI 22 in BI receiving recess 14. Next, the BI presence sensors 52, 1
26 sends a signal to microprocessor 132 indicating that BI 22 is present in BI receiving cavity 14. Next, the microprocessor 32 reads the BI
The stepper motor 32 is controlled so that the fluorescence sensor circuit 46 is arranged close to the depression. After the desired wetting period (ie, after breaking the ampoule and properly wetting the BI), a reference reading indicating the autofluorescent behavior of the BI is read. Then, at regular time intervals, the subsequent fluorescence readings are read to establish the desired kinetic characteristics of that particular BI 22 (ie, generate a fluorescence / time profile) and to validate the sterilization cycle for that BI 22 To determine.

It should also be noted that the heater in the culture zone of the device of the present invention can be set to heat to the desired temperature in hardware using a DIP switch or other suitable hardware mechanism. It is. However, the heater is preferably configurable by software, as described above.

Further, in a preferred embodiment where the BI presence sensor is a photoelectric sensor such as an infrared detector, the radiation source of the detector is shut off during the fluorescence measurement. This helps to eliminate errors associated with extraneous radiation entering recess 14. Also, the preferred spacing of the circuit 46 from the recess 14 is about 1 mm. However, any suitable distance may be used that reduces the amount of stray light that enters recess 14. Also, in one preferred embodiment, as soon as system 10 or system 14 is activated, microprocessor 32 cycles through each BI presence sensor to determine whether BI is present in any of wells 14. I do. This continues intermittently until the microprocessor 32 detects the presence of BI in the cavity 14. Next, the processing of the BI starts. BIs can be added asynchronously and a separate exercise profile can be maintained for each BI, regardless of when the exercise profiles of the other BIs 22 have started.

Thus, it can be seen that the biological indicator reader of the present invention has many important advantages. The number of steps for which an operator must handle a particular BI 22 is significantly reduced compared to prior art methods. In addition, many different BIs
Can be processed asynchronously, and the operator does not need to perform complicated management and entry of records. Furthermore, since a plurality of different heating and culture zones are provided, different types of BIs can be treated simultaneously in an effective manner. Also, B
Because the I-receiving recess 14 is configured to collect the fluorescence expressed by the BI 22 (in one preferred embodiment), the amplitude of the signal from the fluorescence sensor is much greater than in prior art systems. As a result, the amount of additional amplification required is reduced and the signal-to-noise ratio associated with the sensor signal is increased.

Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

[Brief description of the drawings]

FIG. 1 is a perspective view of a biological indicator device according to one embodiment of the present invention.

2 is a block diagram of a portion of the biological indicator device shown in FIG.

FIG. 3 is a more detailed block diagram of the flash / sensor circuit shown in FIG.

FIG. 4 is one embodiment of a carriage assembly according to one aspect of the present invention.

FIG. 5 is one embodiment of a heater configuration according to one embodiment of the present invention.

FIG. 6 is a partial side sectional view of the biological indicator reading device shown in FIG. 1;

FIG. 7 is an enlarged view illustrating a BI and a fluorescence sensor according to one embodiment of the present invention.

8A is a top view of a portion of the biological indicator reader shown in FIG.

8B is a top view of a portion of the biological indicator reader shown in FIG.

FIG. 9 is a top view showing another embodiment of the biological indicator reader according to the present invention.

10 is a partial sectional side view of the biological indicator reading device shown in FIG. 9;

FIG. 11 illustrates a second embodiment of an integrated cavity according to one aspect of the present invention.

FIG. 12 is a partial schematic view illustrating a configuration of a fluorescence sensor according to one embodiment of the present invention.

──────────────────────────────────────────────────続 き Continued on the front page F term (reference) 2G045 AA28 AA40 BB19 BB20 CB21 FA01 FA11 FA14 FA18 FA25 FA33 FA40 FB01 FB04 FB07 FB12 FB20 GC15 GC30 JA01 JA07 JA08 2G054 AA02 AA10 AB09 AB10 BA04 BB13 FB20 FA02 FA02 FB03 FB04 FB08 GA01 GA04 GB02 GB04 JA02 JA05 4C058 AA12 BB04 BB05 BB06 DD14 EE26 JJ15

Claims (28)

[Claims] 1. An apparatus for reading a plurality of biological indicators (BI) to determine the effectiveness of a plurality of sterilization cycles, each BI comprising a biological indicator indicative of bacterial growth in said BI. The device, which emits fluorescence in response to activity, comprises: a plurality of BI holders each configured to receive one of the BIs; and a plurality of the BI holders with respect to the plurality of BI holders. A carriage that is controllably movable to a position near each of them, a BI mounted on the carriage, and a BI received by the selected BI holder when the carriage is at a position near the selected BI holder. A radiation emitter arranged to impinge radiation onto the carriage; and a BI mounted in the carriage and in a selected BI holder senses fluorescence developed in response to the impinging radiation. A fluorescence sensor for transmitting a fluorescence signal indicating the detected fluorescence, and a controller coupled to the fluorescence sensor for receiving the fluorescence signal and transmitting an output signal indicating the detected fluorescence. Controlling the position of the carriage, intermittently disposing the carriage close to each BI holder holding the BI at that time, and disposing the carriage close at that time. A controller configured to receive a fluorescence signal indicative of the fluorescence sensed from the BI corresponding to the BI holder being configured. 2. The apparatus of claim 1, further comprising a memory coupled to the controller, wherein the controller is configured to store data indicative of each BI fluorescence based on the received fluorescence signal in the memory. The described device. 3. An output device coupled to the controller, the output device providing an operator-perceptible indicator indicating the effectiveness of a plurality of sterilization cycles based on data stored in the memory. The apparatus of claim 2, wherein the apparatus is configured to: 4. The output device comprises a plurality of displays, one display associated with each BI holder, each of the plurality of displays associated with a BI received in the BI holder associated with the display. 4. The device of claim 3, wherein the device provides an indication of the effectiveness of one of the plurality of sterilization cycles. 5. An optical sensor, wherein the fluorescent sensor is arranged to receive a fluorescent light expressed by a BI and to transmit a sensor signal indicating the detected fluorescent light; and The apparatus of claim 1, further comprising a sensor controller receiving and coupled to the controller, the sensor controller configured to transmit a fluorescence signal based on the sensor signal. 6. The apparatus of claim 5, wherein said sensor controller is coupled to and controls said radiation emitter. 7. The fluorescent sensor further comprises a reference sensor coupled to the sensor controller, the reference sensor sensing radiation emitted from the radiation emitter and the sensor controller based on the sensed radiation. The apparatus of claim 5, wherein the apparatus is arranged to transmit a reference signal to the sensor, and the sensor controller is configured to transmit the fluorescence signal based on the reference signal. 8. Each of the plurality of BI holders has an inner wall surface, the inner wall surface comprising:
Having a receiving hole for receiving an associated BI and a first sensing passage therethrough, wherein the optical sensor is positioned with respect to the first sensing passage so as to pass through the sensing passage.
Apparatus according to claim 5, wherein the apparatus receives fluorescence emitted from I. 9. The system further comprising a plurality of container presence detectors coupled to the controller, one of the plurality of container presence detectors being associated with each of the plurality of BI holders and associated with the associated BI holder. The apparatus of claim 8, wherein the apparatus transmits a presence signal indicating whether a BI is present. 10. An emitter, each of said plurality of container presence detectors being coupled to said controller and disposed proximate to an associated BI holder for impinging radiation on BI received in said associated BI holder. And a detector coupled to the controller and disposed proximate to an associated BI holder for conditionally detecting radiation and transmitting the presence signal based on the detected radiation. The described device. 11. The interior wall includes a second sensing passage therethrough, and a detector of an associated container presence sensor is arranged to detect light emitted from the emitter and passing through the second sensing passage. The device of claim 10, wherein 12. Each BI holder has an end substantially opposite the receiving hole,
The apparatus of claim 11, wherein the second sensing passage is located closer to the end than the receiving hole. 13. A reflective portion is formed on the inner surface, the reflective portion being arranged to reflect at least a part of the fluorescence emitted by the BI in the BI holder in the direction of the first sensing passage. Equipment. 14. The apparatus of claim 13, wherein said reflective portion is substantially parabolic. 15. The apparatus of claim 13, wherein said reflective portion is substantially hemispherical. 16. The apparatus of claim 8, wherein said optical sensor comprises a filter system configured to filter radiation other than a wavelength substantially related to said fluorescence. 17. A motor, further comprising: a link mechanism coupled to the motor and the carriage, the motor configured to drive movement of the carriage through the link mechanism. An apparatus according to claim 9. 18. The system according to claim 18, wherein said controller includes a motor controller coupled to said motor for controlling said motor, said controller controlling said motor to move said carriage to an associated BI holder and having a BI in an associated BI holder. 18. The apparatus of claim 17, wherein the apparatus is configured to move to a position proximate to the BI holder in response to the presence signal from the container presence detector associated with the BI holder, the indication indicating: 19. A first heater, comprising: a first heater; and a second heater, wherein the plurality of BI holders are mounted in operable proximity to the first heater and receive heat from the first heater. The apparatus of claim 1, comprising: a plurality of BI holders; and a second plurality of BI holders operably mounted proximate to the second heater and receiving heat from the second heater. 20. The first heater is configured to heat the first plurality of BI holders to a first temperature, and the second heater is configured to heat the second plurality of BI holders to the first temperature. 20. The method according to claim 19, wherein the second temperature is different from the first temperature.
The described device. 21. An operator input device coupled to the controller, further comprising an operator input device configured to receive the operator input and to transmit an operator input signal based on the operator input. First and second heaters receive respective temperature input signals indicating the first and second temperatures and, based on the temperature input signals, respectively move the first and second plurality of BI holders to the first and second BI holders. And a second heater, the first and second heaters being coupled to the controller, the controller receiving an operator input signal indicative of the first and second temperatures and receiving the operator input signal. 21. Transmitting the temperature input signal to the first and second heaters respectively based on the signal. The placement of the device. 22. An apparatus for reading a plurality of biological indicators (BI) to determine the effectiveness of one or more sterilization cycles, wherein the BIs are indicative of bacterial growth in the BI. A device that develops fluorescence in response to a human activity, the device comprising a plurality of holders, each configured to receive one of a plurality of containers, and a portion of the received BI. A holder provided with a passage for exposing each of the plurality of holders; a heater coupled to the plurality of holders, for heating the plurality of holders to at least one preselected temperature; and a plurality of positions close to each of the plurality of holders. A carriage that is movable with respect to the plurality of holders between the plurality of holders, and that moves with the carriage and moves along with the carriage to the passage in the holder selected from the plurality of holders. A radiation source configured to be movably aligned and emitting radiation through the passageway in the selected holder when the carriage is in a position proximate the selected holder; Attached and moved with the carriage, the BI in the selected holder is configured to sense fluorescence emerging through the passage in the selected holder and transmit a sensor signal indicative of the sensed fluorescence. And a fluorescent sensor attached to the carriage and moved with the carriage, connected to the fluorescent sensor and the radiation source, receiving the sensor signal, and transmitting a fluorescent signal based on the sensor signal. And a first controller configured. 23. The apparatus of claim 23, further comprising: a second controller connected to the first controller; and a memory connected to the second controller, wherein the second controller is connected to the plurality of BIs by the first controller. Receiving a plurality of fluorescent signals, storing data indicative of the fluorescent signals in the memory, storing a motor response profile associated with each DI, and storing the motor response profiles of each DI asynchronously with each other. 23. The device of claim 22, wherein the device is configured as: 24. The apparatus of claim 2, further comprising a motor coupled to the carriage and driving the carriage between a plurality of positions proximate to the plurality of DI holders.
3. The device according to 3. 25. A DI presence sensor coupled to the plurality of DI holders, the DI presence sensor sensing the presence of DI in the BI holders and transmitting a BI presence signal indicating whether or not BI exists in the BI holder. 25. The device of claim 24 comprising. 26. An infrared emitter, wherein the BI presence sensor is arranged to emit infrared radiation toward a portion of the BI holder that receives the BI, and whether the BI is present in the BI holder. 26. The apparatus of claim 25, further comprising: an infrared detector coupled to conditionally receive infrared light based on the received light. 27. Each E3I holder comprises an inner surface formed of a material that reflects at least a portion of the fluorescence emitted by the BI toward the passage contained in a BI container received in the BI holder. An apparatus according to claim 26. 28. The heater, comprising: a first heater; and a second heater, wherein the plurality of BI holders are operatively attached to the first heater and receive heat from the first heater. 28. The apparatus of claim 27, comprising: a first plurality of BI holders for receiving; and a second plurality of BI holders operably mounted proximate to the second heater for receiving heat from the second heater. .